Home / 510(k) Clearances / K212641

510(k) K212641

StrataMR II Valves and Shunts by Medtronic Neurosurgery — Product Code JXG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 16, 2021
Date Received
August 20, 2021
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Shunt, Central Nervous System And Components
Device Class
Class II
Regulation Number
882.5550
Review Panel
NE
Submission Type

Other clearances by Medtronic Neurosurgery

  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242034 — Duet External Drainage and Monitoring System (EDMS) (October 24, 2024)
  • K181622 — StrataMR guider tool (October 1, 2018)
  • K161370 — Durepair Dura Regeneration Matrix (November 2, 2016)
  • K152700 — StrataMR Valves and Shunts (April 7, 2016)
  • DEN120017 — Medtronic DUET External Drainage and Monitoring System (August 22, 2014)
  • K123524 — MEDTRONIC STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (February 13, 2013)
  • K110560 — MEDTRONIC ARES ANTIBIOTIC-IMPREGNATED CATHETER (November 18, 2011)
  • K091312 — PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM (September 2, 2009)
  • K083076 — STRATA BURR HOLE VALVE, MODEL 42836 AND STRATA BURR HOLE SHUNT ASSEMBLY, MODEL 4 (November 20, 2008)

Other clearances for product code JXG

  • K251598 — Intellidrop (December 10, 2025)
  • K250636 — Sophy Mini Monopressure Valve (SM1) (November 28, 2025)
  • K252514 — EVAC-MRI (November 5, 2025)
  • K243531 — Codman Libertís Shunt Catheter with Bactiseal and Endexo Technology (August 8, 2025)
  • K243552 — Codman Libertís™ 1.5 mm EVD Catheter with Bactiseal® and Endexo® Technology with (August 6, 2025)
  • K242974 — External CSF Drainage Ventricular Catheters, External CSF Drainage Lumbar Cathet (June 20, 2025)
  • K243205 — EVAC (June 3, 2025)
  • K243676 — Duet External Drainage and Monitoring System (EDMS) (March 10, 2025)
  • K242003 — XABO Ventricular Catheter, XABO Peritoneal Catheter, XABO Catheter Set (December 16, 2024)
  • K241458 — Borvo EVAC System (Ergo); Borvo EVAC System (Classic) (August 20, 2024)